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PDA BioAB Members Keep Busy in First Half of 2016

Oct 03, 2016

PDA’s Biotechnology Advisory Board (BioAB) hit the ground running in the first half of 2016 and its activities continue to gain momentum. BioAB members help PDA establish its strategic direction and provide oversight for the Association’s biopharmaceutical scientific and technical activities. The following are a few highlights of BioAB members’ activities from the first part of the year.

In June, Vince Anicetti, Senior Vice President, Quality and Compliance, Coherus Bioscience, and Stephan Krause, PhD, Director, QA Technology, AstraZeneca Biologics, co-chaired the 2016 PDA Biosimilars Conference in Baltimore. Michael VanDerWerf, Director, Regulatory Affairs, Teva, and Laurie Graham, PhD, Acting Director, Division of Internal Policies and Programs, OPQ, U.S. FDA, helped moderate the sessions. Over 120 attended the conference, representing a number of international companies actively pursuing manufacturing of biosimilars, leaving with a better appreciation of FDA’s analytical comparability approach and its similarities and differences with EMA’s approach. Following the conference, Stephan Krause and John Geigert, PhD, President, BioPharmaceutical Quality Solutions, taught two new biosimilar courses they had developed for the PDA Education program.

Also in June, Karen Walker, Global Head, Quality, Cell and Gene Therapies Unit, Novartis, covered how to manage raw material risks for cell and gene therapies at the Advanced Therapy Medicinal Products conference in Berlin. Here, attendees expressed the need for further PDA guidance to help better understand the challenges of taking one’s product from development to the clinical stage. John Geigert also taught another PDA Education course in conjunction with this meeting. This was a new course on practical GMPs for ATMPs, adapted from GMP principles on proteins described in PDA Technical Report No. 56: Application of Phase-Appropriate Quality Systems and CGMP to the Development of Therapeutic Protein Drug Substance.

On the regulatory side, Vijay Chiruvolu, Senior Director, Kite Pharma, is now serving as team lead for PDA’s review of the FDA draft guidance on Comparability Protocols. Nadine Ritter, President, Global Biotech Experts, is also serving as team lead of the PDA commenting team for the FDA draft guidance on analytical methods validation for immunological methods.

BioAB members also reviewed and recommended for publication Technical Report No. 74: Reprocessing of Biopharmaceuticals and Technical Report No. 75: Consensus Method for Rating 0.1μm Mycoplasma Reduction Filters. Both were published this summer.

BioAB members continue to work hard for PDA. Please give them a round of thanks for their continuing service to you.


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